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CompletedNCT00667043Cool SedationUpdated Dec 29, 2023

Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

A Phase 4 interventional study of remifentanil and propofol and fentanyl and midazolam in Hypothermia, sponsored by Norwegian University of Science and Technology. Completed at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Norwegian University of Science and Technology · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.

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Conditions studied

  • Hypothermia

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Keywords

  • therapeutic hypothermia
  • cardiac arrest
  • sedation
  • remifentanil
  • propofol
  • fentanyl
  • midazolam
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In context

Hypothermia

499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 351 interventional studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
  • Patients must be 18 years or older
  • Inclusion must be approved by the attending physician

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
  • Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
  • History of drug allergies, or contraindications for the study drugs
  • Patients using a scheduled dose of any of the study drugs.
  • Patients with a known substance abuse of opioids or benzodiazepines
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Study group 1

    Midazolam and fentanyl; continuous intravenous infusions

    Drug: fentanyl and midazolam

  • Active comparator
    Study group 2

    Propofol and remifentanil; continuous intravenous infusion

    Drug: remifentanil and propofol

Interventions

  • Drugremifentanil and propofol

    Patients will receive: propofol, continuous intravenous infusion, concentration 10 mg/ml, 1-4 mg/kg/hour and remifentanil; continuous intravenous infusion 0,050 mg/ml, 0.1-0.3 microgram/kg/min. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.

  • Drugfentanyl and midazolam

    Patients will receive: midazolam; continuous intravenous infusion, concentration 5 mg/ml, 2-10 mg/hour and fentanyl; continuous intravenous infusion, concentration 0,050 mg/ml, 0.025-0.5 mg/hour. Drugs are administered to sedate the patients as part of normal treatment for as long as sedation is needed. Doses are titrated to achieve the desired level of sedation.

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What researchers measure

Primary outcomes

  1. time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.

    Time frame: 2010

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Study locations

2 sites
  • Stavanger University Hospital
    Stavanger, Rogaland 4068, Norway
  • St. Olavs Hospital
    Trondheim, Sør-Trøndelag 7006, Norway
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References and documents

Publications

  • Bjelland TW, Dale O, Kaisen K, Haugen BO, Lydersen S, Strand K, Klepstad P. Propofol and remifentanil versus midazolam and fentanyl for sedation during therapeutic hypothermia after cardiac arrest: a randomised trial. Intensive Care Med. 2012 Jun;38(6):959-67. doi: 10.1007/s00134-012-2540-1. Epub 2012 Apr 12. PubMed 22527063 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00667043
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Apr 25, 2008
Start date
Apr 2008
Primary completion
May 2009
Completion
Jun 2010
Last update
Dec 29, 2023

Study contacts

Pål Klepstad, MD, PhD
study director · National Taiwan Normal University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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